Articles by n8n Publisher
GAO Report Exposes Critical Gaps in FDA Medical Device Oversight: What Manufacturers Must Know
By n8n Publisher |
GAO report reveals FDA rarely mandates device recalls and relies heavily on manufacturers. Learn what…
Abiomed Impella Controller Updates: Critical Instructions for Heart Pump Safety Compliance
By n8n Publisher |
Abiomed updates Impella Controller instructions in FDA Communications Pilot, highlighting critical post-market surveillance and IFU…
FDA Communications Pilot: Calyxo Updates CVAC Aspiration System Instructions – What Manufacturers Need to Know
By n8n Publisher |
FDA launches Communications Pilot with Calyxo's CVAC aspiration system instruction update, signaling enhanced recall transparency…
Medical Device Recall Reform: New Accountability Measures and What Manufacturers Must Know
By n8n Publisher |
Medical device recall reforms propose enhanced accountability measures. Learn what manufacturers must do to prepare…
Medical Device Recalls Drop in April 2025: What This Trend Means for Manufacturers
By n8n Publisher |
Medical device recalls declined in April 2025, signaling potential industry improvements in quality management and…
New Congressional Legislation Could Transform Medical Device Recall Requirements for Manufacturers
By n8n Publisher |
New Congressional legislation could transform medical device recall requirements, impacting manufacturer compliance obligations and safety…
New Congressional Legislation Targets Medical Device Recall Reform: What Manufacturers Need to Know
By n8n Publisher |
New Congressional legislation by Senators Schakowsky and Durbin aims to enhance medical device recall processes,…
May 2025 FDA Medical Device Recalls: Critical Compliance Lessons for Manufacturers
By n8n Publisher |
May 2025 FDA device recalls reveal critical compliance gaps. Learn key lessons and actionable strategies…
H.R. 6594: Medical Device Recall Improvement Act Could Transform Recall Management for Manufacturers
By n8n Publisher |
Rep. Schakowsky introduces H.R. 6594 to improve medical device recalls. Learn what this means for…
GAO Report Exposes Critical FDA Staffing Gaps Delaying Medical Device Recalls
By n8n Publisher |
GAO investigation reveals FDA staffing shortages are delaying critical medical device recall oversight, forcing manufacturers…
